Actively Recruiting
Tailored Exercise Training Study Among Adults With Heart Failure With Preserved Ejection Fraction (HFpEF) Comparing Lifestyle Interventions
Led by University of Texas Southwestern Medical Center · Updated on 2025-10-31
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart failure with preserved ejection fraction (HFpEF) is a condition linked to high rates of illness and death, with limited medication options. Exercise intolerance, causing breathlessness and tiredness, is a key symptom that lowers quality of life and raises hospitalization risk. This research focuses on adults with or at risk for HFpEF, aiming to assess the effects of different lifestyle exercise programs on exercise capacity and muscle health. The study has two phases. In Phase I, 120 participants will follow a three-month home-based moderate-intensity continuous training (MCT) program using customized exercise videos on a mobile device, with weekly virtual coaching sessions. This is followed by a three-month period without intervention to observe detraining effects. In Phase II, starting at six months, 100 participants will be randomly assigned to one of four groups for three months: MCT alone; MCT plus resistance training videos; MCT plus weight loss medications; or MCT combined with resistance training and weight loss medications. Participants will be involved in regular assessments including exercise testing, physical performance evaluations, and quality of life questionnaires at baseline, 3, 6, and 9 months. Imaging scans of the chest, abdomen, and pelvis will measure changes in muscle composition. The main outcomes measured are peak oxygen uptake during exercise and physical performance scores. Other health and muscle-related markers will also be tracked to understand the effects of the lifestyle interventions.
CONDITIONS
Brief Title
Tailored Exercise Training Study Among Adults With HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Left ventricular ejection fraction (LVEF) of 50% or higher
- History of HFpEF diagnosis or at risk for HFpEF
- HFpEF diagnosis based on heart failure hospitalization within 12 months or NT-proBNP >360 pg/mL
- Risk of HFpEF based on more than 2 risk factors including diabetes, hypertension, obesity, or physical inactivity
- Short Physical Performance Battery (SPPB) score less than 10 or peak VO2 below 60th percentile
- Body mass index (BMI) of 28 or higher (for phase II randomization)
- Ability to use a cell phone and mobile application
You will not qualify if you...
- Hospitalization within 1 month prior to baseline visit
- History of recurrent falls
- Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m
- Active changes in heart failure therapies within 2 weeks prior to baseline
- Inability to participate in exercise training therapy
- Inability to perform cardiopulmonary exercise testing (CPET)
- Severe left-sided valvular heart disease
- End stage pulmonary disease requiring continuous supplemental oxygen
- Major surgery within 3 months before screening or planned during the study
- Unstable weight with more than 5% change in body weight in the 30 days before the first study visit
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants undergo three months of home-based moderate-intensity continuous training (MCT) using tailored exercise videos on a mobile or tablet, with weekly virtual meetings with a coach to discuss progress.
Weekly virtual meetings during training
Duration - 3 months
Participants have 3 months with no intervention to assess the effects of detraining.
No scheduled visits
Duration - 3 months
Participants are randomized to one of four extended training strategies involving combinations of moderate-intensity continuous training, resistance training, and weight loss interventions for 3 months.
Weekly virtual meetings with a coach during training
Duration - Up to 3 months after intervention
Participants undergo follow-up assessments including exercise capacity and skeletal muscle composition evaluations to measure effects of the interventions.
Follow-up visits at 3, 6, and 9 months for assessments
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75209
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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